maralixibat

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Generic Name:
maralixibat
Project Status:
Active
Therapeutic Area:
Alagille syndrome
Manufacturer:
Mirum Pharmaceuticals Inc.
Call for patient/clinician input open:
Brand Name:
Livmarli
Project Line:
Reimbursement Review
Project Number:
SR0780-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

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Key Milestones2
Call for patient/clinician input openMarch 23, 2023
Call for patient/clinician input closedMay 15, 2023
Clarification:

- Patient input submission received from Alagille Syndrome Alliance and Canadian Liver Foundation

Submission receivedMay 05, 2023
Submission acceptedMay 19, 2023
Review initiatedMay 23, 2023
Draft CADTH review report(s) provided to sponsor for commentAugust 04, 2023
Deadline for sponsors commentsAugust 16, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 12, 2023
Draft recommendation posted for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 02, 2023
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingFebruary 28, 2024
Draft recommendation issued to sponsorMarch 11, 2024
Draft recommendation posted for stakeholder feedbackMarch 21, 2024
End of feedback periodApril 05, 2024